Dey, LP, Napa, Calif, has announced that the Food and Drug Administration has approved its new drug application for Perforomist™ (formoterol fumarate) inhalation solution for long-term, twice-daily maintenance treatment of bronchoconstriction for emphysema and chronic obstructive pulmonary disease (COPD). 

Formoterol is a rapid and long-lasting beta2 agonist that has been previously approved in the United States as a dry-powder formulation, and the molecule has 20 years of worldwide use.  Perforomist  is the first and only FDA-approved nebulized formoterol fumarate. 

The clinical evaluations of Perforomist included two clinical trials involving a total of 1,045 patients.  In the product’s pivotal Phase III trial, 351 patients participated in a 12-week, multicenter safety and efficacy COPD study.  In the study, 123 COPD patients were treated with Perforomist  20 mcg/2 mL twice daily, 114 COPD patients were treated with the active comparator (Foradil®), and 114 COPD patients were treated with placebo.  The study’s results showed that Perforomist inhalation solution 20 mcg/2 mL taken twice daily was statistically superior to placebo for the primary endpoint, FEV1 AUC 0-12.  The safety and efficacy of Perforomist  observed in this study were comparable to those of Foradil®.  Additionally, patients treated with Perforomist  used less rescue albuterol during the trial compared to patients treated with placebo.